ES2682950T3 - Electrosurgical system with an instrument comprising a jaw with a central insulating pad - Google Patents

Abstract

An electrosurgical system comprising: an electrosurgical generator arranged to supply radiofrequency (RF) energy through an electrosurgical instrument that can be connected removably thereto; wherein the electrosurgical instrument comprises: a first jaw; a second jaw opposite the first jaw, wherein the first and second jaws are pivotally arranged to grip tissue between the first and second jaws; a first electrode connected to the first jaw; and a second electrode connected to the second jaw, wherein the first and second electrodes of the first and second jaws are arranged to transmit radiofrequency energy between the first and second electrodes to fuse and cut tissue between the first and second jaws with central portions of the first and second jaws facing each other and which are free of electrodes, wherein a central portion of the first jaw comprises an insulating part that faces a central portion of the second jaw, characterized in that the insulating part is a pad of compatible rest and because the second jaw comprises a central projecting part that corresponds to the position of the pad

Description

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DESCRIPTION

Electrosurgical system with an instrument comprising a mandfoula with a central insulating pad Background

The present application refers to an electrosurgical fusion / sealing and dissection system.

Electrosurgical devices or devices that use electrical energy to perform certain surgical tasks have been made available. ^ electrosurgically, basically, electrosurgical instruments are surgical instruments such as clamps, scissors, tongs, scalpels, needles that include one or more electrodes that are configured to be supplied with electrical energy from an electrosurgical generator. Electric energy can be used to coagulate, fuse or cut the tissue to which it is applied.

Typically, electrosurgical instruments fall into two classes: monopolar and bipolar. In monopolar instruments, electrical energy is supplied to one or more electrodes in the instrument with high current density while a separate return electrode is electrically coupled to a patient and is often designed to minimize current density. Monopolar electrosurgical instruments may be useful in certain procedures but may include a risk of certain types of injuries in patients such as electric burns that are often at least partially attributable to the operation of the return electrode. In bipolar electrosurgical instruments, one or more electrodes are electrically coupled to a source of electrical energy of a first polarity and one or more other electrodes are electrically coupled to a source of electrical energy of a second polarity opposite to the first polarity. Bipolar electrosurgical instruments, which operate without separate return electrodes, can supply electrical signals to a targeted tissue area with reduced risks. Document No. US 2003/125728 A1 describes a system comprising an electrosurgical instrument with jaws having peripheral electrodes and insulating central portions.

However, even with the relatively focused surgical effects of bipolar electrosurgical instruments, surgical results are often highly dependent on the surgeon's skills. For example, thermal tissue damage and necrosis can occur in cases where electrical energy is supplied for a relatively long duration or where a relatively high power electrical signal is supplied, even for a short duration. The rate at which a tissue will achieve the desired clotting or cutting effect after the application of electric energy is based on the type of tissue and can also vary based on the pressure applied to the tissue by means of an electrosurgical device. However, it may be difficult for a surgeon to evaluate how quickly a mass of combined tissue types caught in an electrosurgical instrument will fuse a desired amount.

Compendium

A laparoscopic fusion / sealing and dissecting electrosurgical instrument is provided that is configured to fuse and cut tissue simultaneously. The electrosurgical device or instrument includes a first jaw and a second jaw opposite the first jaw to grab tissue between the first and second jaws. The first jaw includes an electrode and the second jaw includes an electrode. The electrodes of the first and second jaws are arranged to fuse and cut tissue between the first and second jaws using radiofrequency energy with central portions of the first and second jaws facing each other that are devoid of an electrode.

In several cases, an electrosurgical instrument comprises a first mandible with a first electrode having a first surface area to make contact with the tissue and a second electrode with a second surface area to make contact with the tissue. The first surface area is the same as the second surface area. The instrument also includes a second jaw opposite the first jaw and coupled to the first jaw to grab tissue between the first and second jaws. The second jaw includes a third electrode that has a third surface area to make contact with the tissue and a fourth electrode that has a fourth surface area to make contact with the tissue. The third surface area is equal to the fourth surface area and the fourth surface area is larger than the first surface area. The first and third electrodes are arranged to fuse tissue between the first and second jaws using radiofrequency energy on one side of a longitudinal axis and the second and fourth electrodes are arranged to fuse tissue between the first and second jaws using radiofrequency energy on a opposite side of a longitudinal axis.

An electrosurgical system is provided to fuse and simultaneously cut tissue. The system comprises an electrosurgical generator and an electrosurgical fusion / sealing device and instrument and dissector. The generator includes an RF amplifier and a controller. The RF amplifier supplies RF energy through an extra-stable coupled electrosurgical instrument, e.g. eg, an electrosurgical fusion and dissector instrument, configured to fuse and cut tissue only with RF energy. The controller is arranged to monitor a phase angle of the supplied Rf energy, wherein the controller signals the RF amplifier to increase the voltage of the supplied RF energy when the monitored phase angle is greater than zero and increases. In several cases, the controller signals the RF amplifier to stop the RF energy supplied when the

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Phase angle monitored decreases.

Many of the auxiliary features will be more easily perceived, since they are better understood with reference to the previous description and the following, and when considered in connection with the attached drawings.

Brief description of the drawings

The present system can be better understood by taking it in connection with the accompanying drawings in which reference numerals designate similar parts throughout all the figures thereof.

FIG. 1 is a perspective view of an electrosurgical system.

FIG. 2 is a perspective view of an electrosurgical generator.

FIG. 3 is a perspective view of an electrosurgical instrument.

FIG. 4 is a perspective view of a distal end of the electrosurgical instrument.

FIG. 5 is a perspective view of a distal end of the electrosurgical instrument.

FIG. 6 is a cross-sectional view of a distal end of an electrosurgical instrument.

FIG. 7 is a cross-sectional view of a distal end of an electrosurgical instrument.

FIG. 8 is a cross-sectional view of a distal end of an electrosurgical instrument of a system according to the present invention.

FIG. 9 is a cross-sectional view of a distal end of an electrosurgical instrument of a system according to the present invention.

FIG. 10 is a cross-sectional view of a distal end of an electrosurgical instrument.

FIG. 11 is a graphical representation of experimental data samples for a fusion and dissection process with an electrosurgical instrument.

FIG. 12 is a graphical representation of experimental data samples for a fusion and dissection process with an electrosurgical instrument.

FIG. 13 is a graphic representation of experimental data samples for a fusion and dissection process with an electrosurgical instrument.

FIG. 14 is a cross-sectional view of a distal end of an electrosurgical instrument.

FIG. 15 is a flow chart illustrating operations of an electrosurgical system.

FIG. 16 is a schematic block diagram of portions of an electrosurgical system.

FIG. 17 is a schematic block diagram of portions of an electrosurgical system.

FIG. 18 is a schematic block diagram of portions of an electrosurgical system.

FIG. 19 is a flow chart illustrating operations of an electrosurgical system.

FIG. 20 is a flow chart illustrating operations of an electrosurgical system.

FIG. 21 is a flow chart illustrating operations of an electrosurgical system.

FIG. 22 is a graphical representation of experimental data samples for a system FIG. 23 is a graphical representation of experimental data samples for a system FIG. 24 is a graphical representation of experimental data samples for a Detailed Description system

Generally, a bipolar fusion / sealing electrosurgical instrument, device, or dissector and dissector is provided to simultaneously fuse and cut captured tissue between the jaws of the instrument. The jaws include particularly positioned, molded and / or oriented electrodes together with a compressible resting pad to optimally perform simultaneous fusion and cutting of tissue. The bipolar electrosurgical fusion and dissector instrument can also fuse or cut tissue separately. Tissue cutting is done especially without the use of a mechanical cutting knife, the use of a cutting electrode

electrosurgical

electrosurgical

electrosurgical

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particular or central or shear forces or scissors movement. The instrument is provided for use in laparoscopic cio ^ with a maximum diameter of 5 mm and, therefore, can be inserted through a 5 mm trocar.

Additionally, in general, an electrosurgical system is provided which includes an electrosurgical generator and an extrafole coupled electrosurgical instrument, e.g. eg, a fusion and dissector instrument, which is configured to merge and optimally cut tissue. The RF energy is supplied by the electrosurgical generator that is arranged to provide the appropriate RF energy to fuse and cut the tissue. The generator determines the appropriate RF energy and the appropriate way to deliver the RF energy to the particular connected electrosurgical instrument, the particular tissue in contact with the instrument and / or a particular surgical procedure. Operationally, adjustment or fusion of tissue RF between the jaws is provided to decrease adjustment time, output voltage, output power and / or thermal diffusion. The efficient and consistent power supply to the tissue is provided to heat the tissue through a temperature range at a particular rate that has been found to be optimal for the tissue effect.

With reference to FIGS. 1-2, an electrosurgical system is illustrated which includes an electrosurgical generator 10 and an extrafole connectable electrosurgical instrument 20. The electrosurgical instrument 20 can be electrically coupled to the generator via a wired connection 30 to a tool or device port 12 in the generator. The electrosurgical instrument 20 may include auditory, tactile and / or visual indicators to inform a user of a particular predetermined state of the instrument such as a start and / or end of a fusion or cut operation. In other cases, the electrosurgical instrument 20 may be reusable and / or connectable to another electrosurgical generator for another surgical procedure. In some cases, a manual controller such as a hand or foot switch may be connectable to the generator and / or instrument to allow a predetermined selective control of the instrument such as to begin a fusion or cutting operation.

The electrosurgical generator 10 is configured to generate radiofrequency (RF) electrosurgical energy and can be configured to receive data or information from the electrosurgical instrument 20 electrically coupled to the generator. The generator 10, in one case, emits RF energy (e.g., 375 VA, 150 V, 5 A at 350 kHz) and, in one case, is configured to calculate an angle or phase difference between the voltage of RF output and RF output current during activation or supply of RF energy. The generator regulates the voltage, current and / or power and monitors the RF energy output (e.g., voltage, current, power and / or phase). In one case, the generator 10 stops the RF energy output under predefined conditions, such as when a device switch is released (e.g., a fuse button is released), a time value is reached, and / or an active phase angle and / or a phase change is greater than or equal to a phase and / or a phase stop value change.

The electrosurgical generator 10 comprises two advanced bipolar tool ports 12, a standard bipolar tool port 16 and an electric power port 14. In other cases, the electrosurgical units may comprise different numbers of ports. For example, in some cases, an electrosurgical generator may comprise more or less of two advanced bipolar tool ports, more or less of the standard bipolar tool port and more or less power ports. In one case, the electrosurgical generator comprises only two advanced bipolar tool ports.

Each advanced bipolar tool port 12 is configured to engage an electrosurgical instrument that has a fixed or integrated memory module. The standard bipolar tool port 16 is configured to receive a non-specialized bipolar electrosurgical tool that differs from the advanced bipolar electrosurgical instrument connectable to the advanced bipolar tool port 12. The electrical power port 14 is configured to receive or connect to an accessory device of direct current (DC) that differs from a non-specialized bipolar electrosurgical tool and the advanced electrosurgical instrument. The electrical power port 14 is configured to supply DC voltage. For example, in some cases, power port 14 may provide approximately 12 volts DC. The power port 14 can be configured to power a surgical accessory, such as a respirator, a pump, a lamp or other surgical accessory. Therefore, in addition to replacing an electrosurgical generator with standard or non-specialized bipolar tools, the electrosurgical generator can also replace a surgical accessory power supply. In some cases, the replacement of generators and power supplies, which currently exist, with the electrosurgical generator can reduce the amount of storage space required on slats or shelf shelves for storage by the number of network power cords required in a surgical work area.

In one case, connecting a non-specialized bipolar tool to the standard bipolar port will not cause the generator to actively verify the tool. However, the generator recognizes a connection in such a way that the information of the non-specialized bipolar tool can be displayed. In some cases, the generator recognizes the device connection status for each of the advanced tool ports 12 and authenticates the connected devices before accepting RF energy activation requests (e.g., activating a power switch). instrument such as a fuse button). The generator, in one case, reads authenticated data from the connected device and reads electrical control values (such as, but not limited to, voltage level adjustments, current level adjustments, power level adjustments, adjustments of active phase angle levels, rF energy emission activation time limits, instrument short circuit limits, open limits of

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instrument, instrument model / identification, RF Jan emission line settings, switching status command settings and / or combinations thereof) of the authenticated and connected device.

In some cases, the electrosurgical generator 10 may comprise a viewfinder 15. The viewfinder can be configured to indicate the status of the electrosurgical system that includes, among other information, the status of the one or more electrosurgical instruments and / or accessories, connectors or connections of the same. In some cases, the viewer may comprise a multi-line viewer capable of presenting text and graphic information, such as, for example, a Liquid Crystal Display (LCD) panel viewer, which in some cases may be You can illuminate by rear light or side light. In some cases, the viewfinder may comprise a multicolored viewfinder that can be configured to display information about a particular instrument electrically coupled to the electrosurgical generator and a color corresponding to a particular surgical procedure (such as, for example, cutting operations displayed in text and yellow graphics, fusion or welding operations displayed in purple, and coagulation displayed in blue, bloodless dissection operations displayed in yellow and blue).

In some cases, the display can be configured to simultaneously indicate status data for a plurality of instruments electrically coupled to the electrosurgical generator and / or be portioned to display status information for each instrument connected to a corresponding tool port. A visual indicator, such as a status bar graph, can be used to illustrate a proportion of the total available electrical energy that is applied when the bipolar electrosurgical instrument is operated. In several cases, an electrosurgical instrument operable to cut, seal, coagulate or fuse tissue could have three color-coded bar visors or graphs. In some cases, a user can toggle the viewfinder between the presentation of the state of multiple electrically connected instruments and the state of a single electrically connected instrument. In some cases, once an instrument and / or accessory is connected and / or detected, a window opens in the user interface viewer that shows the type of instrument connected and the status.

The electrosurgical generator may comprise a user interface such as, for example, a plurality of buttons 17. The buttons may allow user interaction with the electrosurgical generator such as, for example, the request for an increase or decrease in electrical energy supplied to one or more instruments coupled to the electrosurgical generator. In other cases, the viewer 15 can be a touch screen viewer thus integrating data viewer and user interface functionalities. In some cases, through the user interface, the surgeon can configure a tension adjustment by selecting one to three levels. For example, at level 1, the voltage is adjusted to 110 V; at level 2, the voltage is set to 100 V; and at level 3, the voltage is adjusted to 90 V. The current is adjusted to 5 A and the power is adjusted to 300 VA for all three levels. In other cases, the voltage is preset or by default at a specific level such as level 2. In other cases, like the current and power settings, the voltage setting is not adjustable by the user to simplify the operation of the generator and, as such, a default default voltage setting is used, e.g. eg, the voltage is set to 110 V.

In one case, the electrosurgical tool or instrument 20 may additionally comprise one or more memory modules. In some cases, the report includes operational data regarding the instrument and / or other instruments. For example, in some cases, operational data may include information regarding electrode configuration / reconfiguration, instrument uses, operating time, voltage, power, phase and / or current settings, and / or operating states, conditions, scripts, processes or particular procedures. In one case, the generator reads and / or writes in the memory module.

In one case, each advanced bipolar electrosurgical instrument comes with a memory module and / or an integrated circuit that provides authentication, configuration, expiration and registration of the instrument. The connection of such instruments in the plugs or ports initiates a process of verification and identification of the instrument. Instrument authentication, in one case, is provided by a challenge-response scheme and / or a stored secret key also shared by the generator. Other parameters have hash keys for integrity checks. The uses are registered in the generator and / or in the integrated circuit and / or instrument memory. Errors, in one case, may result in use without registration. In one case, the log register is set in binary and interpreted with instruments outside the line or through the generator.

In one case, the generator uses time measurement components to monitor an expiration of the instrument. Such components use oscillators or polling timers or real-time calendar clocks that are set for the boot time. Timer interrupts are handled by the generator and can be used by scripts for timeout events. The log also uses timers or counters to mark the time of recorded events.

In some cases, the generator provides the ability to read the phase difference between the voltage and current of the RF energy sent through the connected electrosurgical instrument while the RF energy is active. While the tissue is fusing, phase readings are used to detect different states during the process of fusion or sealing and cutting.

In one case, the generator records usage details in an internal register that can be downloaded. The generator has memory for code storage and machine performance. The generator has a reprogrammable memory

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which contains instructions for a specific instrument performance. Memory, for example, retains a serial number and instrument usage parameters. The generator stores information about the type of connected instruments. Such information includes, but is not limited to, an instrument identifier, p. eg, a serial number of a connected instrument, along with a time stamp, number of uses or duration of use of the connected instrument, power adjustment of each and changes made to the default setting. The memory, in one case, maintains data for approximately two months, approximately 10,000 instrument uses or up to 150 registered activations and is configured to overwrite, as necessary.

The generator, in some cases, does not monitor or control the current, power or impedance. The generator regulates the voltage and can adjust the voltage. The electrosurgical power supplied is a function of the tension, current and impedance of the tissue applied. The chamber, through voltage regulation, affects the electrosurgical power that is being supplied. However, as the voltage increases or decreases, the electrosurgical power supplied does not necessarily increase or decrease. Power reactions are caused by the power that interacts with the tissue or the condition of the tissue without any control by a generator other than the generator that supplies power.

Once the generator begins to supply electrosurgical power, it does so continuously or periodically, e.g. eg, every 150 ms, until a fault occurs or a specific phase parameter is reached. In one example, the jaws of the electrosurgical instrument can be opened and, thereby, the compression is relieved at any time before, during and after the application of electrosurgical power. The generator, in one case, also does not stop or wait for a particular duration or a predetermined time delay to begin the termination of electrosurgical energy.

With reference to FIGS. 3-14, a bipolar electrosurgical fusion and dissector instrument 20 is provided. In the illustrated case, the instrument 20 includes an actuator 24 coupled to an elongated rotating shaft 26. The elongated shaft 26 has a proximal end and a distal end defining a central longitudinal axis therebetween. At the distal end of the shaft 26 are the jaws 22 and at the proximal end is the actuator. In one case, the actuator is a handle similar to a pistol grip. The shaft 26 and the jaws 22, in one case, are sized and modeled to fit through a trocar cannula or 5 mm diameter access port.

The actuator 24 includes a mobile handle 23 and a handle or stationary housing 28, with the mobile handle 23 coupled and movable in relation to the stationary housing. In some cases, where the mobile handle 23 is slidably and pivotally coupled to the stationary housing. In operation, the mobile handle 23 is manipulated by a user, e.g. eg, a surgeon, to operate the jaws, for example, by opening and closing the jaws selectively. In some cases, the actuator 24 includes a force regulation mechanism that is configured such that in a closed configuration the jaws 22 provide a grip force between a predetermined minimum force and a predetermined maximum force.

As part of the force regulation mechanism, the mobile handle 23 is coupled to the stationary handle in two sliding pivot locations to form the force regulation mechanism. The mobile handle has a first end that includes a grip surface formed thereon and a second end opposite the first end. The mobile handle is coupled to a pin adjacent to the second end. In some cases, the mobile handle can be formed integrally with a protusion that extends from it that defines a pin surface, while in other cases, a pin can be snapped into an opening in the mobile handle. The pin may be contained within grooves in the stationary housing, such as a corresponding groove formed in right and / or left handle frames of the stationary housing. In some cases, the grooves can be configured to define a desired drive handle path, such as a curved or angled path, as the drive handle moves from the first position that corresponds to the open jaws to a second position corresponding to the closed jaws. The force regulation mechanism includes an inclination member, such as a tension spring, which tilts the pin in a proximal direction. In operation, as a predetermined force is exerted by the movement of the mobile handle, an inclination force exerted by the spring is overcome, and the second end of the mobile handle can generally be moved distally, guided by the pin in the grooves.

In some cases, the movable handle pivotally and pivotally engages the stationary housing 28 at a location between the first and second ends of the drive handle. A drive member, such as a drag block, is coupled to the drive handle. When the mobile handle moves proximally, the drag block also moves proximally and longitudinally, closing the jaws 22, thereby holding any tissue between the jaws. The drag block, in some cases, is rectangular, with open upper and lower faces and a closed proximal end. The mobile handle extends through the upper and lower faces of the drag block. An edge of the movable handle rests on the proximal end of the drag block such that the movement of the movable handle relative to the stationary housing moves the drag block longitudinally. A distal end of the drag block, in one case, is coupled to a drive shaft such as a drag tube, rod or rod, which can extend longitudinally along the elongated shaft 26. Therefore, in operation, the movement of the mobile handle from the first position to the second position translates the drag block longitudinally within the stationary housing which, correspondingly, moves the drag tube generally linearly along the longitudinal axis with respect to the elongated axis 26. The movement of This drag tube can control the relative movement of the jaws 22.

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In some cases, the actuator 24 includes a hitching mechanism to keep the movable handle 23 in a second position with respect to the stationary housing 28. In several cases, the movable handle comprises a hitch arm that joins a corresponding hitch element contained within of a stationary handle to keep the mobile handle in a second position or closed position. The actuator, in some cases, also comprises a wiring that includes isolated individual electrical wires or cables contained within a single sheath. The wiring can leave the stationary housing on a lower surface thereof and be part of the wired connection. The wires within the wiring can provide electrical communication between the instrument and the electrosurgical generator and / or accessories thereof.

In some cases, the actuator includes one or more cables attached to rotating coupling clips configured to allow infinite rotation of the shaft. In several cases, a switch is connected to an activation button 29 manipulated by a user and activated when the activation button is pressed. In one aspect, once activated, the switch completes a circuit by electrically coupling at least two wires together. As such, therefore, an electrical path of an electrosurgical generator is established towards the actuator to supply RF energy to the cables attached to the rotating coupling clips.

In one case, the actuator includes a rotating shaft assembly that includes a rotating knob 27 that is disposed on an outer cover tube of the elongated shaft 26. The rotating knob allows a surgeon to rotate the shaft of the device while gripping the actuator 24 In some cases, the elongated shaft 26 comprises a drive tube that couples the jaws 22 to the actuator. In several cases, the drive tube is housed within an outer cover tube. While the drive tube is illustrated as a generally tubular member that can be housed inside the outer cover tube, in other cases, a non-tubular drive member can be used, for example, an axle, a rigid band or an articulation that , in certain cases, it can be positioned inside the outer cover tube.

In some cases, the rotating shaft assembly is fixed to the distal end of the outer cover tube comprising two matching ends and a conductive sleeve. The extremities connect to each other, joining the outer cover tube. In other cases, the extremities may be of a monolithic construction and be configured to interconnect with the matching characteristics in the outer cover tube. The conductive sleeve can be fixed to the proximal portion of the assembled limbs after they are fixed to the outer cover tube. When the conductive jacket is fixed to the back of the assembled limbs, the jacket retains the exposed end of an insulated wire. In the illustrated case, the insulated wire extends from its point of imprisonment under the conductive jacket through a groove in the actuation tube and then into a protective jacket. The protective jacket and the insulated wire extend distally inside the drive tube, towards the jaws. In other cases, the insulated wire can be formed integrally with a protective sheath and a separate protective jacket is not present in the drive tube.

The jaws 22 are fixed to the distal end of the elongated shaft comprising a first jaw 70 and a second jaw 80. In one case, a jaw pivot pin pivotally couples the first and second jaws and allows the first jaw to be able to be move and pivot in relation to the second jaw. In several cases, a jaw is fixed with respect to the elongated axis so that the opposite jaw pivots with respect to the jaw fixed between an open and a closed position. In other cases, both jaws can be pivotally coupled to the elongated shaft so that both jaws can pivot, with respect to each other.

The jaw geometry provides specific pressure profiles and specific current densities in specific locations to produce the required fusion / sealing and dissection effect. Operationally, the temperature required to achieve the sealing and division is minimized while the cross-linking of proteins within the vascular structure is maximized, thus maximizing the efficiency of fusion / sealing and tissue division.

In some cases, to monitor the temperature of the biological reaction, the phase angle and / or the rate of change of the phase angle are monitored. It has been found that the phase angle provides an indication of the temperature of the biological reaction and an indication that tissue division has occurred. In some cases, the device uses bipolar RF energy for electrosurgery to cut and fuse tissue between the jaws when they open or close and / or when they are in contact with the lower jaw when the jaws are open or closed. In one case, tissue temperature is monitored during the sealing and / or division cycle.

The advanced bipolar electrosurgical device uses bipolar RF energy for both sealing and fusion and tissue division or cutting. As such, the device maintains the cellular structure of tissue adjacent to the area of division while applying the energy required for tissue division. Other RF dissection devices use a localized arc formation or an opening of sparks to vaporize the tissue and achieve dissection. This may be acceptable for a straight tissue dissection because it is not intended to seal or fuse the surrounding area, but it is different from the fusion and dissection devices and systems described herein.

The advanced bipolar electrosurgical device, in some cases, also considers the high heat associated with tissue vaporization or tissue dissection. As such, the device, in some cases, uses a temperature control to minimize the energy required to achieve tissue division. By minimizing the energy required, the temperature

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during the reaction it is less and the cell structure is less likely to be altered due to the high emission of energy.

It is necessary to keep the cellular structure of the tissue in operation when it is fused and dissected or divided simultaneously, because it is necessary for the seal to occur adjacent to the area of division. The addition of the open cutting and sealing mode also reduces the number of devices or the exchange of devices used in performing a surgical procedure as such or all the functionalities of such individual devices are provided in the single advanced bipolar laparoscopic device.

The electrosurgical instrument comprises mobile jaws capable of capturing tissue between them. In one case, the jaws include an upper jaw that closes over a static lower jaw. The upper jaw may include a nested upper jaw member 41, an upper conductive pad 42, a nipple insulating pad 43, a wire 44 and a compressible rest pad 45 that are joined together using an insert molding process and, of that way, it is provided as a unique structure or assembly, as shown in FIG. 6.

Both the nested upper jaw member and the upper conductive pad are active electrodes that have opposite polarities. The compressible rest pad provides a surface with a specific spring constant to ensure that contact and pressure occurs between the rest pad and the length of the lower jaw. The upper conductive pad 42 is electrically insulated from the upper jaw member nested 41 by the resting pad 45 and the insulating pad 43. In several cases, the upper jaw is made of stainless steel and is more nigged than the resting pad 45. The resting pad 45 can be made of silicone and is more flexible than the upper jaw member 41 or the conductive pad 42. The insulating pad is made of a non-conductive material and can be as sharp or more than the upper jaw member. 41 or the conductive pad 42. In several cases, the upper jaw member 41 and the conductive pad are made of the same material.

The upper jaw member 41 and the conductive pad have a lower outer surface arranged to be in contact with the tissue. The lower surfaces are angled or inclined and reflect images with each other with such positioning or orientation that facilitate focused current densities and tissue retention. The compressible rest pad 45 has a lower surface arranged to be in contact with the tissue and / or the lower jaw. In the illustrated case, the resting pad is flat and not parallel with respect to the inclined lower surfaces of the upper jaw member and the conductive pad 42. The positioning or orientation of the lower surface of the resting pad can help focus on current densities, hold the tissue and facilitate the electrical dissection of tissue. The spring constant of the resting pad, in several cases, is predetermined to provide optimum pressure or force to cause or facilitate electrical tissue division.

The lower jaw comprises a lower jaw member nested 52, a lower conductive pad 53, a cutting electrode 55, two insulated nipples 54, 56, as well as two wires, one for the conductive pad and one for the cutting electrode, in where all are joined together using an insert molding process and thus provided as a unique structure or assembly as shown in FIG. 7, The nested lower jaw member 52, the lower conductive pad 53, and the cutting electrode 55 are all active electrodes or act as such. The lower conductive pad 53 and the cutting electrode 55 have the same polarity and are electrically isolated by the two insulated nipples 54 and 56 of the nigged lower jaw member having the opposite polarity.

The lower jaw member 52 and the conductive pad 53 have an upper outer surface arranged to be in contact with the tissue. The upper surfaces are angled or inclined and reflect images with each other with such positioning or orientation that facilitate focused current densities and tissue retention. In several cases, the lower jaw is made of stainless steel and is as sharp or as sharp as the conductive pad 53. The insulated nipples 54, 56 are made of a non-conductive material and can be as sharp or nigger than the member of lower jaw 52 or conductive pad 53. In several cases, lower jaw member 52 and conductive pad 53 are made of the same material.

The general configuration of the mandible, according to various embodiments, is shown in cross section in FIG. 8 and demonstrates the interaction of the geometries (eg, shape, dimension, material and any combination thereof for optimal fusion and dissection) between the upper jaw and the lower jaw. In operation, the conductive pads 42, 53 have the same polarity. The upper and lower jaw members 41, 51, 52 have the same polarity, but the polarity opposite to the conductive pads 42, 53. In one case, the cutting electrode 55 is only active during a cutting and fusion operation and is the opposite polarity of the lower jaw member 52. As illustrated, the rest pad 45 interferes and is compressed on the lower jaw member 52 and the conductive pad 53 after the jaws are closed. The tissue (not shown), also captured between the lower jaw and the upper jaw is compressed between the rest pad 45 and the lower jaw member 52 and the conductive pad 53.

The polarity of each electrode is adjusted to create the appropriate RF energy and heating due to the current

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electric that passes between them. As shown in FIG. 9, the current flow direction allows heating between the conductive pads and the jaw members, as well as the creation of heating from side to side in the lower jaw configuration, as exemplified by the arrows 101. The heating of Side by side in the lower mandfoula configuration is provided for tissue division, as exemplified by arrow 102. To divide the tissue by half of the mandfoula, the tissue is heated to reach a temperature between 60 ° C and 100 ° C to denature the collagen present in the tissue. Once the collagen has been denatured, it enters a state similar to a jelly.

Since the tissue is gelatinous or in a gelatin-like state, the spring constant and the interference of the silicone resting pad cause a mechanical separation of the tissue, as exemplified in FIG. 10 and arrow 103. In several cases, the spring constant is predetermined to optimize the separation of the tissue by interference with the pad and the lower jaw, such that the resting pad compresses a predetermined distance or amount according to the tissue between them and with minimal or no effects on the adjacent tissue. Therefore, the configuration of the electrodes allows simultaneous heating of the sealing area (the area between the conductive pads and the jaw members) and the cutting area (the region of current from side to side on the lower jaw). Collagen denaturation is also the mechanism used to create a tissue seal or fusion. The seal uses the same temperature (60 ° C to 100 ° C) as the cut, but the jaw seal spacing between the conductive pads and the jaw members creates a shape or mold for the seal to re-cross once that the RF application ceases. It should be noted that reaching high temperatures quickly can cause the cell structure to break due to rapid heating of intracellular moisture. Therefore, a gradual increase in temperature and a longer residence time in the appropriate temperature range allow for more complete denaturation of the collagen.

In several cases, to reach the appropriate tissue temperature to cause the effect of associated tissue, e.g. For example, a gradual increase and / or longer residence time, the phase angle of the tissue and / or the rate of change of the phase angle are monitored. The FlGs. 11-13 provide a graphic representation of exemplary sealing and division cycles. Also, as illustrated, phase 111g is shown in relation to other tissue readings or indicators such as voltage 111a, power 111b, impedance 111c, energy 111d, temperature 111e and current 111f. Additionally, although it is shown in FIGS. 11-13, in several cases, the generator is configured not to measure or calculate one or more of the indicators or readings, p. eg, temperature or energy, to reduce costs and operational and power consumption and / or the number of generator parts. Additional information or readings are generally provided or displayed for context purposes.

As shown in FIGS. 11-13, the temperature of tissue 111e between the jaws increases from the beginning of the RF energy to a point of the higher phase angle. At this point of the highest phase angle (or the inflection point of the phase angle change rate) 155 the temperature stagnates 150 momentarily (~ 0.75 seconds), then continues higher 152, even when the voltage decreases

It should be noted that momentary temperature stagnation can be attributed to the change in the state of water or moisture present in the tissue. When the water begins to boil, the temperature does not increase until the liquid water has become water vapor. Temperature determination 111e as such can be based on phase angle 111g. The temperature before the maximum phase angle is associated with constant heating at 100 ° C. Temperature stagnation is associated with a sudden decrease in the phase angle that can be associated with 100 ° C and with water of two states. Because liquid water is highly conductive and water vapor is not, this phase transition may be another indicator of water status. Once the temperature continues to rise beyond 100 ° C (152) and beyond a second phase angle turning point 160, it can be seen that the water mayonnaise has become water vapor.

Another point of interest that can be seen in the RF output is the sudden peak 170 in power 111b and current 111f during boiling of the water portion of the application of Rf, as shown, for example, in FIG. 13. The peak can be attributed to tissue division during the sealing or fusion process. This increase in power and current may be due to the fact that the tissue is no longer present below the isolated portion of the jaws, e.g. eg, the resting pad. At this point, the jaw is closed more and the transfer of energy is only through the sealing surfaces.

Because the temperature required to denature the collagen starts at 60 ° C, the energy application is optimized to maximize the time before 100 ° C. This provides a complete and deep denaturation of the collagen. As such, all sealing must be completed before peak 170 in power and current so that the sealing is completed before division.

The electrosurgical instrument also has the ability to cut tissue using RF energy and in one case only with the jaws in a fully open position, only using the lower jaw, without the cooperation of the upper jaw or the non-captured tissue between the upper jaws and lower but in contact with the lower jaw. FIG. 14 shows the direction of current flow, arrow 140, of the cutting electrode 55 to the lower jaw member nested 52.

To achieve tissue cutting, a high voltage potential is created between the cutting electrode 55 and the member of

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lower mandfoula 52. This provides tissue vaporization due to the heat created by the local arc formation around the cutting electrode. As it is at high temperature, the insulating material used to insulate the cutting electrode, in one case, resists or operates well at high temperatures. Also, with the high voltage potential, the insulator, in one case, has a high dielectric resistance. The voltage potential is greater than the 400 V peak to achieve sufficient arc formation. The real potential, however, is directly related to the spacing between the cutting electrode and the lower jaw member.

Arc suppression is another concern and, as such, rapid rectification of the RF waveform distortion due to arc formation and / or limiting power emission is provided to prevent degradation of the materials used in the construction of the jaw. If an arc is allowed to persist for more than 100 microseconds, there is an increased risk of device degradation. Also, due to the extreme heat associated with the localized arc formation, the application of rF energy in several cases includes a predetermined duty cycle or waveform with a high crest factor. It has been found that the crest factor associated with a sine waveform does not allow constant emission without causing degradation of the device. The manipulation of the duty cycle or crest factor reduces the average output power during the entire activation of the device.

The electrosurgical instrument also fuses tissue using RF energy and, in one case, only with the jaws in a fully open position, only using the lower jaw, without the cooperation of the upper jaw or uncaptured tissue between the upper and lower jaws , but in contact with the lower jaw. FIG. 14 exemplary illustrates a direction of current flow from the cutting electrode 55 to the lower jaw member nested 52.

In some cases, to cause tissue coagulation, a low voltage potential is maintained between the cutting electrode 55 and the lower jaw member 52. The voltage potential is adjusted to be less than a 100 V peak to avoid the localized arc formation, but the real potential is directly related to the spacing between the cutting electrode and the lower jaw member. Clotting of tissue is caused by the heat generated by the RF current between the two electrodes.

In one case, the insulated wire 44 is routed to electrically couple the first jaw to the wiring in the actuator. The insulated wire extends from the distal end of the protective jacket that is housed in the proximal end of the second jaw and extends into the first jaw. The first jaw can have a slot positioned to receive the insulated wire. The insulated wire then extends through a hole in the first jaw and falls into a slot in a non-conductive portion. The insulated wire then extends to the distal end of the non-conductive portion and falls through the conductive pad.

In some cases, the electrode geometry of or in the conductive pads of the jaws ensures that the sealing area completely closes the distal portion of the cutting path. In some cases, the dimensions of the jaw surfaces are such that they are properly provided with respect to the optimum pressure applied to the tissue between the jaws for the potential force that the force mechanism can create. Its surface area is also electrically significant with respect to the surface area that makes contact with the tissue. This proportion of the surface area and the thickness of the tissue have been optimized with respect to its relation to the relative electrical properties of the tissue.

In one case, as illustrated in FIG. 15, an electrosurgical process, such as a process of fusion and / or tissue cutting, begins by pressing a switch on the tool (151), which begins an initial measurement sequence. With the coupling of a switch to the tool, the generator takes initial measurements on the tissue (openings, short circuit) (152) and based on the initial measurements starts or does not start the RF energy supply (153). In some cases, the generator measures the tool and / or tissue impedance and / or resistance, and / or if a phase angle is within an acceptable range. In one case, the generator performs a passive measurement of tissue between the electrodes of an electrosurgical tool connected to the generator using RF energy with a low energy range (e.g., a voltage of approximately 1-10 volts) that does not cause a physiological effect In several cases, the generator uses the initial impedance measurement to determine if the tool is shorted, defective, open. Based on a positive result of the initial verification, the generator, for example, switches an RF energy supply from the generator to the electrosurgical tool and finally to the tissue (154). After the RF power is turned on and the generator supplies it continuously, the generator monitors the phase angle or difference and / or phase angle change between the current and voltage of the supplied RF energy (155).

At or after a predefined or predetermined point, condition or threshold (156), the RF power supply (157) is terminated. In this case, an acoustic and / or visual serial is provided that indicates that the tissue was fused (or that an error has occurred (e.g., a short circuit of the electrodes) and / or that an unexpected condition has occurred (p e.g., release of allowable switch although unexpected)). In some cases, the predefined point, condition or threshold and / or initialization checks are determined based on a tool algorithm or script that is provided for a connected electrosurgical tool, procedure or preference. In some cases, the product of the measured tissue permittivity and conductivity or an initial phase change is used to determine the end point for a connected tool.

Referring now to FIG. 16, in one case, the electrosurgical generator 10 is connected to an input

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AC main and a power supply 141 converts AC voltage from the main AC input to DC voltages to power several sets of generator circuits. The power supply also supplies DC voltage to an RF amplifier 142 that generates RF energy. In one case, RF amplifier 142 converts 100 VDC from the power supply to a sine waveform with a frequency of 350 kHz that is supplied through a connected electrosurgical instrument. The RF sensor circuitry set 143 measures / calculates the voltage, current, power and phase at the output of the generator in which the RF energy is supplied to a connected electrosurgical instrument 20. The measured / calculated information is supplied to a controller 144.

In one case, the RF sensor analyzes the AC voltage and current measured from the RF amplifier and generates DC signals to control signals that include voltage, current, power and phase that are sent to the controller for further processing. In one case, in RF sensor 143 it measures the output voltage and current and calculates the average square root (RMS) of the voltage and current, the apparent power of the RF energy output and the angle of phase between the voltage and current of the RF energy that is supplied through a connected electrosurgical instrument. In particular, the voltage and current of the output RF energy are processed by an analog circuitry set of the RF sensor to generate real and imaginary components of both voltage and current. These signals are processed by a field-programmable gate arrangement (FPGA) to give different measurements related to voltage and current, including RMS measurements of the AC signals, the phase change between voltage and current, and power. Therefore, in one case, the voltage and output current are measured in analog, they are converted to digital, they are processed by an FPGA to calculate the RMS of the voltage and current, apparent power and the phase angle between the voltage and the current, and then converted back to analog by the controller.

For each device port there is a pair of signals for voltage and a pair of signals for current originating from RF amplifier 142. In one case, the generator has two redundant RF sensor circuits 143a, 143b that measure the voltage and current for each device in different locations in the RF amplifier. The first RF detection circuit detects current by means of detection resistors supplied through an electrosurgical instrument connected in the device port 1 or in the device port 2, and the transverse measured voltage is re-emitted in the device port 1 or at the device port 2. The second RF detection circuit detects current by means of detection resistors, which return from an electrosurgical instrument connected to the device port 1 or the device port 2, and the measured voltage 146a, 146b transversely it is emitted to return to device port 1 or device port 2. The voltage input signals are 350 kHz high-voltage sine waveforms that are attenuated and the AC is coupled by a voltage divider and a filter inverter to eliminate DC polarization in the signals. An inverter filter is used since the voltage and current inputs are 180 degrees out of phase because they are measured at opposite polarities. For each voltage input signal, two separate inverted and non-inverted voltage sensor signals are generated. In one case, a differential voltage measurement is made between the current input signals to generate two separate pairs of inverted and non-inverted current sensor signals. The current input signals represent the voltage across a shunt resistor in the RF amplifier in which this voltage is proportional to the current flowing through the shunt resistor. The current input signals are low voltage sine waveforms at 350 kHz that are amplified using a non-inverting filter to eliminate DC polarization in the signals. The RF sensor generates a signal that is analogous to multiply each voltage and current signal by predetermined reference signals. As such, the Rf sensor provides the non-inverted voltage and current sensor signals when the waveform is positive, the voltage and current sensor signals reversed when the waveform is negative, and a signal from the ground when the Waveform is zero.

The RF sensor, in some cases, receives four reference synchronization signals supplied by the controller via the RF amplifier. The synchronization signals are impulse signals of 350 kHz with the same duty cycle but with phase changes that differ and in one case, 90 degrees are offset between sf. Two of the synchronization signals are used to generate the phase waveforms to generate the actual component of the input waveforms and the other two synchronization signals are used to generate the quadrature waveforms to generate the imaginary components of the input waveforms. These signals are further processed to generate control signals for a plurality of switches. The outputs of the switches are joined to generate a single output. In one case, the control signals for the switches determine which input signal passes to the only output. In some cases, a first combination allows non-inverted voltage and current sensor signals to pass through to represent or be analog to multiply these sensor signals by a positive pulse. A second combination allows the inverted voltage and current sensor signals to pass through to represent or be analog to multiply these sensor signals by a negative pulse. A third combination allows the signal from the ground to generate a zero voltage emission that represents or is analogous to multiplying the sensor signals by zero. Each emission is supplied to a low-pass filter that generates a DC voltage that corresponds to the real or imaginary component of the detected signals. These signals are supplied to CDA (analog-digital converter) that send a digital signal to the FPGA.

In one case, controller 144 controls RF amplifier 142 to affect the output RF energy. For example, the controller uses the information provided by RF sensor 143 to determine whether RF energy should be emitted and when to terminate the RF energy emission. In one case, the controller compares a predetermined phase threshold based on a particular tissue in contact with the electrosurgical device 20 connected to

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Determine when to terminate the January Jan issue of RF. In several cases, the controller performs a fusion process described in greater detail below, and in some cases the controller receives instructions and adjustments or script data to perform the fusion process from data transmitted from the electrosurgical instrument .

In some cases, as shown in FIG. 17, the generator has six main subsystems or modules of circuit assemblies that include System Power or Power Supply 145, Controller 144, Front Panel Interface 146, Advanced Bipolar Device Interface 147, RF Amplifier 142 and the RF sensor 143. In some cases, one or more of the circuit assemblies can be combined or incorporated with another circuit assembly. Power supply 145 is configured to provide DC voltages to all other circuit assemblies or subsystems together with control signals to control power supply emissions. The power supply receives an AC power input that is 90 - 264 V AC, 47 - 63 Hz and, in one case, the power supply has a switch, integrated or separate, that is configured to connect or disconnect the AC power input of the generator. The controller, through the Front Panel Interface (hereinafter FPI) and the Advanced Bipolar Device Interface (hereafter ABDI), supports the user interface 121 and the instrument connections for electrosurgical devices 1 and 2 connected to the electrosurgical generator.

The RF amplifier 142 generates high power RF energy to pass through a connected electrosurgical instrument and, in an example, an electrosurgical instrument to fuse tissue. The RF amplifier, in some cases, is configured to convert a 100 VDC source power to a high power sine waveform with a frequency of 350 kHz that is supplied through ABDI 147 and, eventually, the connected electrosurgical device. The RF sensor 143 interprets the AC voltage and current measured by the RF amplifier 42 and generates DC control signals that include voltage, current, power and phase, which are interpreted by the controller 144.

The generator has a plurality of specialized connection plugs, in the case illustrated, the device port 1 and the device port 2, which are used only for connection to advanced bipolar devices, such as an advanced bipolar electrosurgical instrument. Each of the specialized plugs includes a set of spring loaded probes or Pogo type pins. The generator, in several cases, includes a circuit to detect the presence of an advanced bipolar device before energizing any active output terminals on the plugs.

The Front Panel Interface (FPI) 146 is configured to operate a viewfinder, the device signals of the controllers and the LED back lights (electro-luminescent diode) for the front panel buttons. The FPI is also configured to provide power isolation through regulators and provides functionality for the front panel switches / buttons. In one case, ABDI 147 is used as a pass-through connection that provides a connection to the devices through the FPI. The FPI also provides a connection between controller 144 and an electrosurgical device connected through the ABDI. The device interface, in one case, is electrically isolated from the rest of the FPI. The interface, in several cases, includes lines that read and write in a random access ferromagnetic memory (hereinafter FRAM) in an advanced bipolar device, read a trip switch and / or read a signal indicating that a device. In one case, a device memory circuit is provided that uses the Peripheral Serial Interface (sPi) of the controller to read and write the FRAM of the advanced bipolar device. In one case, the FRAM is replaced with a microcontroller and the interface includes an interruption line. The FPI provides isolation for the SPI signals to and from the advanced bipolar device through the ABDI. In one case, the SPI interface is shared between two advanced bipolar devices with port pins that are used as chip selections.

In some cases, the generator includes an SPI communication bus that allows the controller to have bi-directional communication with complex programmable logic devices (hereafter, CPLD) and RF sensor FPGAs. In several cases, the FPI provides an SPI interface between the controller and connected devices through an ABDI connector to communicate with the FRAM on advanced bipolar devices. The FPI also provides electrical isolation for low voltage signals between controller and ABDI. The device interface in the ABDI is configured to transmit rF energy to the connected device together with the SPI communication. In one case, the ABDI connects a signal from a device that indicates that it is connected.

The FPI-ABDI interface provides power to the devices that connect to the generator, SPI communication between the controller and the devices, the device switch signals from the devices to the controller, and the signals from the device connected from the devices to the controller. The ABDI provides RF energy to each advanced bipolar device connected through a separate Pogo type pin assembly. The FPI provides signal, low voltage power and high RF voltage power of the FPI and the RF amplifier to the device connected through the ABDI connector via the Pogo type pin assembly.

In some cases, an operations engine allows the generator to be configurable to adapt to different operational scenarios, which include, but are not limited to, different and numerous electrosurgical tools, surgical procedures and preferences. The operation engine receives and interprets data from an external source to specifically configure the operation of the generator based on the received data.

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The operation engine receives the configuration data from a database script file that is read from a device memory on a device plug. The script defines the state logic used by the generator. Based on the determined state and the measurements made by the generator, the script can define or adjust output levels, as well as the disconnection criteria. The script, in one case, includes trigger events that include indications of a short circuit condition, for example, when a measured phase is greater than 70 degrees or an open condition, for example, when a measured phase is less than - 50 degrees

In one case, the operations engine provides system states and user states. System states are predefined or predetermined states that control or manage specific predefined or predetermined generator operations, such as the successful application of RF energy or the indication of an error. The system states, in one case, are a predefined configuration setting in which the system can be (eg, off versus energized) and whose functions are preprogrammed in the electrosurgical generator. For example, a Full RF state is a system state that indicates that an RF energy cycle has been completed without errors. User states provide a framework through which you can establish customized or specialized operations and values by address from an external source for a particular tool, procedure and / or preference.

In one case, the script exposes the system states and their output conditions, e.g. eg, expiration times or pointers or addresses to another state and where user states begin. For each user state, the operating parameters for the specific state such as power, voltage and current settings can be defined or transmitted from a previous state. In one case, the user states can provide specific device, operator or procedure states and in one case, the user states can be provided for specific test or diagnostic states.

With reference to FIG. 18, the generator 10 receives the script information of the electrosurgical device or instrument 20 when the device is connected. The generator uses this script information to define a number of states and the order of execution of the states.

The script file or script information 180 written by the device script author and not resident in the instrument or in the generator 10 is text or user readable. The script information is compiled using a script compiler 185 to generate a database or script binary file (hereinafter SDB) of device 101. The script binary file is transferred by a device key programmer 187 to a memory module that is connectable or incorporated into the electrosurgical instrument 20 by means of a device key 182. Since the electrosurgical instrument is connected to the electrosurgical generator, the generator authenticates the binary script file and / or the instrument (188). The generator validates the script binary file (189) and if validated, the operation engine uses the script initiated by the drive by the connected instrument (190). The script source file in one case is a text file that contains a script device that is specific to a specific electrosurgical instrument, generator and / or surgical procedure. The script source file for a device, in one case, includes information that contains parameters and a script (states, functions, events) for the electrosurgical generator and / or electrosurgical instrument. After a successful validation, the script compiler assembles data in a binary format that defines a state machine for use by the electrosurgical generator. The script compiler, as shown in FIG. 18, in one case, is separated from the electrosurgical generator and is responsible for reading the script source file in the text and validating its contents.

When the memory module is inserted into the generator, the generator downloads a binary file that is stored in a random access ferromagnetic memory (FRAM) or microcontroller disposed within the module. The binary includes logic to implement the algorithms or treatment processes. The generator, in several cases, includes firmware / software, hardware or combinations thereof, responsible for processing the binary to authenticate the connected instrument and for executing the binary to perform the processing algorithm. In this way, the generator is configured to operate only with authenticated and compatible hand tools.

In one case, script scripts or script databases represent an instrument process for a given or specific instrument. The instrument scripts are stored in a memory connected or integrated to an instrument, the controller or a combination thereof. The event handler responds to specific events, such as a switch on / off, instrument positions or excess measurement thresholds. The operation engine, based on the detected event, if appropriate for a given event, provides output to the connected instrument. In one case, an event is a discrete change, since a switch is held or released.

A script state is a block or set of script functions or operating conditions and events or script indicators. The script functions are configurable instructions to control the generator and / or instruments. Script operators are logical and comparison operations performed during a sequence event evaluation of

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Commands The script parameters are configuration data used by all the states and events of a script and, in one case, are declared in its own dedicated section of the script file. Script events are discrete changes in an electrosurgical generator measurement. When a Command Sequence Event occurs, for example, a sequence of script functions is executed.

In some cases, the phase angle between the voltage and current and / or the change or phase angle rate is used to maximize the amount of time in which the tissue is in a predetermined temperature range. In one case, the predetermined temperature range is between 60 degrees C to 100 degrees C. In one case, low voltage is used to minimize the effects of temperature while accelerating the sealing or fusion time.

The tissue should be grasped between the jaws of the bipolar electrosurgical device. RF energy is supplied to the bipolar electrosurgical device connected extra-flexibly to an electrosurgical generator, which, after a command, is supplied to the tissue. RF energy must be supplied at a predetermined voltage range to heat the tissue at a predetermined rate. In one case, the predetermined voltage range is between 20 VRMS to 50 VRMS. During the RF energy application, the phase angle between voltage and output current is monitored to identify phase increases or decreases. Initially, the phase angle is monitored to determine a change in angle or phase rate from increase to decrease. It is contemplated that once this inflection point has occurred, it is determined that the water in the jaws of the device has reached 100 degrees C and the temperature has been exceeded to cause the required tissue effect. Therefore, a disconnection point is determined to terminate the RF power supply.

An exemplary RF energy control process for the electrosurgical generator and an associated electrosurgical tool for fusing tissue are shown in FIGS. 19-21 In several cases, as illustrated in FIG. 19, RF energy is supplied by the generator through the connected electrosurgical tool (251). The generator monitors at least the phase and / or the change / phase rate of the RF energy supplied (252). If a phase / phase change is greater than zero or positive trend (253), the voltage (254) is increased. The generator continues to monitor at least the phase and / or the change / phase rate of the supplied RF energy (255). If the phase / phase change continues to increase (256), the generator continues to monitor the phase and / or phase change. If the phase / phase change decreases (257), the process is terminated or termination procedures are initiated and / or the RF energy supplied by the generator (258) is stopped.

In one case, before the start of the process, the impedance is measured to determine a short circuit or an open condition through a low voltage measurement signal supplied to a connected electrosurgical tool. In one case, the passive impedance is measured to determine if the seized tissue is within the operating range of the electrosurgical tool (2-200Q). If the initial impedance check is passed, RF energy is supplied to the electrosurgical tool. After which the impedance / resistance is not measured or ignored.

Initially, the initial parameters are adjusted to prepare the sealing of tissue seized between the jaws. In one case, the voltage and current settings are adjusted for a specific setting. In one case, the RF energy voltage is applied in an increase mode that starts from 30% of a global setting or a level selected by the user (eg, 27.5-88 V for level 1 , 25.0-80 V for level 2 and 22.5 V-72 V for level 3). The DAC voltage (D / A converter) is adjusted to 30% of the voltage setting that is 25.5 VRMS at level 2 (medium). The phase is monitored to determine a phase angle above zero degrees and to heat the tissue and water between the jaws of the electrosurgical device at a predetermined slow rate.

Referring now to FIGS. 20-21, in several cases, RF energy is supplied by the generator through the connected electrosurgical tool (251). The generator monitors at least the phase and / or the change / phase rate of the RF energy supplied (252). If a phase / phase change is greater than zero or positive trend (253), the voltage (254) is increased. In several cases, the voltage is increased at a predetermined rate, for example, 50% for 5 seconds, which is 42.5 VRMS at level 2 (medium) after the phase has increased to be greater than zero degrees. The increase continues until a predetermined condition is satisfied. In one case, the increase continues as the monitored phase angle increases above five degrees. This ensures that the phase is increasing as expected based on tissue heating.

In a subsequent state (265) below, if the monitored phase angle increases above a predetermined phase value, p. For example, 5 degrees, the phase for a growing state or condition continues to be monitored. If it is contemplated that such an increasing condition is an indication that the temperature of the tissue and water between the jaws is increasing but at less than 100 degrees C. However, the monitored phase indicating a decreasing state or condition provides a different indication. It is contemplated that such an indication is that the temperature of the tissue and the water between the jaws has reached at least 100 degrees C and / or the desired tissue effect has been completed, e.g. eg, sealing and / or cutting the tissue.

In one or more subsequent states, the monitored phase angle is verified for an increasing or decreasing condition. In some cases, several incremental or periodic checks are performed along with several incremental or periodic updates for several predetermined thresholds or indications to determine a

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phase angle or increasing rates of change condition or a phase angle or decreasing rates of change condition.

When one or more of the subsequent states determines that the phase angle, rate or trend of the phase angle is decreasing instead of increasing, the indication is that the desired tissue effect has been completed, e.g. eg, sealing and / or tissue cutting. As such, it is contemplated that in such an indication, the temperature of the tissue and water between the jaws has reached at least 100 degrees C.

In such a state or in a later state, the increase in voltage or the increase in the output RF energy is reduced or decreased. As such, rapid boiling of water is reduced or avoided and the temperature remains stable or constant until a predetermined condition is reached. In one case, the default condition is the phase angle that falls to at least 5 degrees.

In some cases, in a subsequent state (266) below, if the monitored phase angle increases above a predetermined phase value, p. For example, 10 degrees, the phase continues to be monitored for a growing state or condition. If, however, on the contrary, the monitored phase angle indicates a decreasing state, p. eg, decreases below a predetermined phase value, e.g. For example, five degrees (268) or a predetermined time limit has been reached, the tension increase (280) stops. Subsequently, if the monitored phase angle continues to indicate a decreasing state, p. eg, decreases below a predetermined phase value, e.g. eg, five degrees (268) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281).

If the monitored phase angle indicates a growing state, p. For example, in a subsequent state (267) below, if the monitored phase angle increases above a predetermined phase value, e.g. For example, 12.5 degrees, the phase continues to be monitored for a state or condition that continues to increase If, on the contrary, the monitored phase angle now indicates a decreasing state, p. eg, decreases below a predetermined phase value, e.g. For example, 7.5 degrees (269) or a predetermined time limit has been reached, the voltage increase (280) stops. Subsequently, if the monitored phase angle continues to indicate a decreasing state, p. eg, decreases below a predetermined phase value, e.g. eg, five degrees (268) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281).

In a subsequent state (270) following, if the monitored phase angle indicates a growing state, e.g. e.g., it increases above a predetermined phase value, e.g. For example, 15 degrees, the increase in tension is stopped (271) and the phase continues to be monitored for a growing state or condition. If, however, on the contrary, the monitored phase angle indicates a decreasing state, p. eg, decreases below a predetermined phase value, e.g. For example, ten degrees (277) or a predetermined time limit has been reached, the tension increase (280) stops. Subsequently, if the monitored phase angle continues to indicate a decreasing state, p. eg, decreases below a predetermined phase value, e.g. eg, five degrees (282) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281). In a subsequent state (272) below, if the monitored phase angle indicates a growing state, e.g. e.g., it increases above a predetermined phase value, e.g. For example, 20 degrees, the phase continues to be monitored for a growing state or condition. If, on the contrary, the monitored phase angle indicates a decreasing state, p. eg, decreases below a predetermined phase value, e.g. For example, ten degrees (277) or a predetermined time limit has been reached, the phase continues to be monitored for a decreasing state or condition. Subsequently, if the monitored phase angle decreases below a predetermined phase value, p. eg, five degrees (282) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281).

In a subsequent subsequent state (273), if the monitored phase angle continues to indicate a growing state, p. e.g., it increases above a predetermined phase value, e.g. For example, 25 degrees, the phase continues to be monitored for a growing state or condition. If, on the contrary, the monitored phase angle decreases below a predetermined phase value, e.g. For example, fifteen degrees (278) or a predetermined time limit has been reached, the phase for a decreasing state or condition is continued. Subsequently, if the monitored phase angle decreases below a predetermined phase value, p. eg, five degrees (282) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281). In a subsequent state (274) below, if the monitored phase angle increases above a predetermined phase value, p. For example, 30 degrees, the phase continues to be monitored for a growing state or condition. If, on the contrary, the monitored phase angle decreases below a predetermined phase value, e.g. For example, fifteen degrees (278) or a predetermined time limit has been reached, the phase for a decreasing state or condition is continued. Subsequently, if the monitored phase angle decreases below a predetermined phase value, p. eg, five degrees (285) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281).

In a subsequent (275) subsequent state, if the monitored phase angle increases above a predetermined phase value, p. For example, 35 degrees, the phase continues to be monitored for a growing state or condition. However, if, on the contrary, the monitored phase angle decreases below a predetermined phase value, e.g. For example, fifteen degrees (278) or a predetermined time limit has been reached, the phase for a decreasing state or condition is continued. Subsequently, if the monitored phase angle decreases below five degrees (282) or if a predetermined time limit has been reached, the RF energy stops and the process

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ends (281). In a subsequent state (276) below, if the monitored phase angle increases above a predetermined phase value, p. For example, 40 degrees, the phase is monitored for a decreasing condition and if the monitored phase angle decreases below a predetermined phase value, p. For example, fifteen degrees (278) or a predetermined time limit has been reached, the phase for a decreasing state or condition is continued. Subsequently, if the monitored phase angle decreases below a predetermined phase value, p. eg, five degrees (282) or if a predetermined time limit has been reached, the RF energy stops and the process ends (281). It is contemplated and observed that, for the sealing / fusion and cutting / dissection process or exemplary and operational system provided above and throughout the entire application, the frequency of incremental verifications and / or indications of increasing or decreasing states, p . e.g., predetermined angles or rates of change, may vary to provide different and diverse levels and granularity of regulation or control as desired or required based on the electrosurgical instrument, generator, tissue and / or specific surgical procedure.

FIGS. 22-24 are graphic representations of sealing / fusion of exemplary vessels using systems and processes. As shown, the success rate 223 of providing a tissue seal above the 3x systolic rupture pressure is high and the time 223 for sealing vessels up to 4 mm in size was small, e.g. eg, less than 2 seconds. The times for sealing vessels between 4-7 mm were also reduced, e.g. eg, less than 5 seconds. The time for the phase angle of the maximum phase value to decrease to a predetermined one, p. eg, 5 degrees, is greater than those up to 4 mm. Such changes or reduction in sealing time, while providing successful vessel sealing, e.g. For example, by supporting a systolic rupture pressure greater than 3x, they can be redefined by identifying and / or firing at the inflection point of the phase tendency derivative and incorporated in incremental verifications, status indicators or thresholds. In several cases, the inflection point of the phase trend derivative is identified as the point where the phase trend changes from a growing state to a decreasing state.

As shown in FIG. 23, the vessel was 6.62 mm in diameter and was successfully sealed, p. eg, having a burst pressure of 87.6 kPa (12.7 psi). Additionally, as shown, the phase angle of 230g increases as RF energy is applied. The rate of increase is not fast but slow enough, as is the temperature 230d of the tissue. The turning point 231, p. For example, the point at which the phase changes from increasing to decreasing occurs at approximately 1.5 seconds before the RF energy stops. As shown in FIG. 24, the vessel was 1.89 mm in diameter and was successfully sealed, p. eg, having a burst pressure of 89.6 kPa (13 psi). The general phase angle trend of 240g and the temperature of 240d is similar to that of the previous vessel seal, although the time scale shown in FIG. 24 is approximately 1/4 that of FIG. 23. Also, as illustrated, phase 230g, 240g is shown in relation to other tissue readings or indicators such as tension 230a, 240a; power 230b, 240b; impedance 230e, 240e; energy 230c, 240c; temperature 230d, 240d; and current 230f, 240f. Additionally, although it is shown in FIGS. 23-24, in several cases, the generator is configured not to measure or calculate one or more of the indicators or readings, p. eg temperature or energy, to reduce costs and operational and power consumption and the number of parts for the generator. Additional information or readings are generally provided or displayed for context purposes.

It should be noted that the impedance of the fabric is close to its minimum during the entire sealing cycle. As such, it provides low voltage and high current and, thus, delivers uniform power throughout the entire sealing cycle. Efficient or uniform power delivery reduces thermal diffusion. In some cases, the time for sealing can be reduced, the reduction in voltage output below 50 VRMS and / or the reduction in power output below 50 watts. To avoid false readings, in some cases, the electrosurgical generator does not measure the resistance or impedance of the tissue during the supply of RF energy to the tissue.

An electrosurgical system is provided that decreases thermal diffusion, provides lower output levels and effective power delivery for sealing vessels or tissue in contact with a bipolar electrosurgical instrument through the controlled and efficient supply of RF energy.

As described throughout the entire application, the electrosurgical generator finally supplies RF energy to a connected electrosurgical instrument. The electrosurgical generator ensures that the RF energy supplied does not exceed specified parameters and detects fault or error conditions. In several cases, an electrosurgical instrument provides the commands or logic used to properly apply RF energy for a surgical procedure. An electrosurgical instrument, for example, includes a memory that has commands and parameters that dictate the operation of the instrument in conjunction with the electrosurgical generator. For example, in a simple case, the generator can supply the RF energy but the connected instrument decides how much or for how long the energy is applied. The generator, however, does not allow the RF power supply to exceed a set threshold even if the connected instrument directs it, thus providing a verification or guarantee against a defective instrument command.

Returning now to some operational aspects of the electrosurgical tool or instrument described herein, once a group of vessels or tissue has been identified to fuse, dissect or both, the first and second jaws are placed around the tissue. The mobile handle 23 is squeezed by moving the mobile handle proximally with respect to the stationary housing 28. Thus the mobile handle moves proximally, the first jaw pivots towards the second jaw effectively securing the tissue. The radio frequency energy is applied

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to the tissue by pressing the activation button on the stationary handle. Once the tissue has been fused, dissected or both, the mobile handle is reopened.

Alternatively or additionally, with the jaws in a fully open position or in an intermediate position between a fully open position and the joined position, radiofrequency energy can be applied to the tissue in contact with a lower surface or a portion of the lower jaw by pressing the activation button or a separate activation button to fuse and / or dissect tissue.

As described generally above and described in greater detail below, several electrosurgical instruments, tools or devices may be used in the electrosurgical systems described herein. For example, clamps, scissors, tongs, probes, needles and other electrosurgical instruments that incorporate one, some or all of the aspects discussed herein can provide several advantages in an electrosurgical system. Several instruments and electrosurgical generators and combinations thereof are discussed throughout the entire application. It is contemplated that one, some or all of the features generally discussed throughout the entire application may be included in any of the instruments, generators and combinations thereof discussed herein. For example, it may be desirable that each of the described instruments include a memory for interaction with the generator, as previously described and vice versa. However, in other cases, the described instruments and / or generators can be configured to interact with a standard bipolar radiofrequency power supply without the interaction of an instrument memory. Additionally, although several systems can be described in terms of modules and / or blocks to facilitate the description, such modules and / or blocks can be implemented by one or more hardware components, e.g. eg, processors, Digital Signal Processors (DSP), Programmable Logic Devices (PLD), Static Application Integrated Circuits (ASIC), circuits, registers and / or software components, p. eg, programs, subroutines, logic and / or combinations of hardware and software components. Likewise, such software components can be exchanged with hardware components or a combination thereof and vice versa.

The above description was provided to allow any person skilled in the art to make and use the surgical instruments and perform the methods described herein. However, several modifications will remain apparent to those skilled in the art. Additionally, different systems or aspects of such systems can be shown in various figures and are described throughout the entire specification. The invention is defined by the claims.

Claims (14)

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An electrosurgical system comprising: an electrosurgical generator arranged to supply radiofrequency (RF) energy through an electrosurgical instrument connectable extrafole thereto; wherein the electrosurgical instrument comprises: a first mandfoula; a second mandfbula opposite the first mandfoula, wherein the first and second mandfoulas are pivotally arranged to grab tissue between the first and second jaws; a first electrode connected to the first jaw; Y a second electrode connected to the second jaw, where the first and second electrodes of the first and second jaws are arranged to transmit radiofrequency energy between the first and second electrodes to fuse and cut tissue between the first and second jaws with central portions of the first and second jaws facing each other and which are free of electrodes, wherein a central portion of the first jaw comprises an insulating part that faces a central portion of the second jaw, characterized in that the insulating part is a pad of compatible rest and because the second jaw includes a central projecting part that corresponds to the position of the pad. 2. The electrosurgical system according to claim 1, wherein the rest pad is compressible and is arranged to be compressed when the jaws grip and fuse tissue between the jaws. 3. The electrosurgical system according to any of the preceding claims, wherein the resting pad is made of silicone and extends along the entire length of the first jaw. 4. The electrosurgical system according to any of the preceding claims, wherein portions of the resting pad on portions of the first jaw adjacent to the electrode of the first jaw can enter into a contact relationship with the electrode on the second jaw. 5. The electrosurgical system according to any of the preceding claims, wherein: the first electrode has a first surface area and the second electrode has a second surface area, where the first surface area is equal to the second surface area; Y The second jaw further comprises a third electrode that has a third surface area, a fourth electrode that has a fourth surface area and a fifth electrode, arranged on a surface that moves away from the first jaw, which has a fifth surface area, where the third surface area is equal to the fourth surface area, the fourth surface area is larger than the first surface area and the fifth surface area is smaller than the first surface area, the first and third electrodes are arranged to fuse tissue between the first and Second jaws using radiofrequency energy on one side of a longitudinal axis and the second and fourth electrodes are arranged to fuse tissue between the first and second jaws using radiofrequency energy on an opposite side of a longitudinal axis. 6. The electrosurgical system according to claim 5, wherein the resting pad on the first jaw in the closed jaw position arranged directly on the fifth electrode and portions of the third and fourth electrodes. 7. The electrosurgical system according to claim 5 or claim 6, wherein the third and fourth electrodes are arranged to cut tissue between the first and second jaws through radiofrequency energy that is conducted between the third and fourth electrodes and wherein The fifth electrode is arranged to cut tissue out of the second jaw through radio frequency energy that is conducted between the fifth electrode and fourth electrode. 8. The electrosurgical system according to any one of claims 5 to 7, wherein the first and fourth electrodes are arranged to have the same polarity of the other and the second and third electrodes are arranged to have the same polarity of the other and different from the polarity of the first and fourth electrodes to fuse tissue between the first and second jaws. 9. The electrosurgical system according to any of the preceding claims, wherein the generator comprises an RF amplifier for supplying RF energy to the instrument configured to fuse and cut tissue and a controller arranged to periodically monitor a phase angle of the RF energy. supplied, where the controller is configured to signal to the RF amplifier that increases the voltage of the supplied RF energy when the monitored phase angle is greater than zero and increases. 10. The electrosurgical system according to claim 9, wherein the controller is configured to signal the RF amplifier to stop the RF energy supplied when the monitored phase angle decreases. 11. The electrosurgical system according to claim 9 or claim 10, wherein the controller is configured to periodically monitor a phase angle change rate of the supplied RF energy and to 5 signal to the RF amplifier that stops the supplied RF energy if the phase angle change rate falls below a predetermined threshold rate. 12. The electrosurgical system according to any of claims 9 to 11, wherein the controller is configured to continue signaling the RF amplifier to increase the RF energy voltage if the monitored phase angle continues to exceed a predetermined threshold angle. The electrosurgical system according to any one of claims 9 to 12, wherein the RF amplifier is set to increase tension at a predetermined constant rate. 14. The electrosurgical system according to claim 13, wherein the RF amplifier is configured to maintain a temperature between the jaws below 100 degrees C while increasing the voltage of the RF energy and to stop the RF energy supplied if the temperature between the jaws begins to exceed 100 degrees 15 C. 15. The electrosurgical system according to claim 13 or claim 14, wherein the controller is configured to signal to the RF amplifier that stops the increase in voltage of the supplied RF energy if the monitored phase angle exceeds a predetermined custom threshold angle that the RF amplifier continues to supply RF energy.